Assessing the Severity of Metabolic-related Liver Injuries in Aging HIV-monoinfected Patients (ANRS ECHAM)
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|ClinicalTrials.gov Identifier: NCT02093754|
Recruitment Status : Completed
First Posted : March 21, 2014
Last Update Posted : July 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection Liver Injuries||Procedure: MRI and biopsy||Not Applicable|
This study is a cross-sectional, multicentre study including 7 centres from 3 European countries (Belgium, France, Germany).
The maximum duration of the study for each patient will be 4 months, consisting of:
- a screening visit,
- an inclusion visit to perform the biologic tests and exams necessary for the study, within 1 month after the screening visit,
- a result delivery visit within 1 month after inclusion visit, to disclose results of previous investigations. Patients with one or two non invasive markers suggesting significant fibrosis (≥F2) will be invited for liver biopsy within the next 2 months.
- a "liver biopsy" visit, within 2 months after visit 2, liver biopsy in selected and consented patients
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||460 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessing the Severity of Metabolic-related Liver Injuries in Aging HIV-monoinfected Patients: a European Multicentre Study|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
- Percentage of steatosis detected by MRI [ Time Frame: Within 6 months after all patients have completed MRI ]
- Percentage of fibrosis or cirrhosis using non invasive markers and concordance of non invasive markers [ Time Frame: Within 6 months after all patients have completed the study ]
- Risk factors (age, duration of infection, treatment, clinical and biological metabolic and adipose tissue parameters) of liver injuries [ Time Frame: Within 6 months after all patients have completed the study ]
- Independent risk factors of NAFLD, NASH and fibrosis (including markers of insulin resistance, inflammatory cytokines, markers of immune activation, adipokines) [ Time Frame: Within 6 months after all patients have completed the study ]
- Establish a diagnosis score based on biomarkers of liver injuries (Adiponectin, leptin, IL6, CRP, CD14) [ Time Frame: Within 6 months after all patients have completed the study ]Quantifiable levels of serum adiponectin, serum leptin, serum HS-IL-6, HS-CRP, serum s-CD14 will be measured.
- Description of pathogenetic factors and correlates with autophagy in liver biopsies of patients with evidence for liver fibrosis [ Time Frame: Within 6 months after all patients have completed the study ]Autophagosome formation in the liver biopsies (only for patients presenting liver fibrosis equal or > 2 will be quantified.
- Identification of features of the adaptive immune system associated to NAFLD, NASH and fibrosis (T cell activation, surface expression of Treg, NK cells, NKT cells) [ Time Frame: Within 6 months after all patients have completed the study ]Quantifiable levels of T cell activation (in PBMC), Frequency and phenotype of Tregs (in PBMC), Quantifiable levels of NK cells (in PBMC), Quantifiable levels of Th17 and γδ T cell (in PBMC), Quantifiable levels of Plasma LPS and LPB (sCD163, CD26, Cytokeratin 18) will be measured.
- Impact of IL28B and PNPLA3 genetic polymorphisms on the severity of liver steatosis, inflammation and fibrosis [ Time Frame: Within 6 months after all patients have completed the study ]
- Percentage of patients with NASH, fibrosis and cirrhosis on liver biopsy [ Time Frame: Within 6 months after all patients have completed the study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02093754
|Hôpital la Salpêtrière|
|Hôpital Saint Antoine|
|Medical Center for Infectious Diseases|
|Center for HIV and Hepato-Gastroenterology|
|University Medical Center|
|Hannover Medical School|
|Principal Investigator:||Maud LEMOINE, MD||Medical Research Council|